General Information

Neulasta is approved as a treatment for patients undergoing
chemotherapy, to decrease the incidence of infection by febrile
neutropenia. It is administered in a single fixed dose per each
cycle of chemotherapy. Neutropenia is a serious and frequent
complication of chemotherapy, especially common in the elderly. As
well as killing cancer cells, chemotherapy destroys normal cells. A
large drop in neutrophils, a type of white blood cell, renders the
body unable to defend itself against most types of infection.

Neulasta provides a great advantage over currently available
white blood cell stimulating products, by requiring less frequent
dosing. This means fewer painful injections, fewer office visits
and fewer disruptions in daily life. Amgen's original
neutropenic protectant, Neupogen, requires up to two weeks of daily
injections after each chemotherapy cycle, with half of patients
needing ten or more each day, as opposed to one injection of
Neulasta.

With approximately 1.4 million patients receiving chemotherapy
in the United States in 2001, protection against neutropenic
infection is very important. This is especially true for the
elderly, who in the next 20 years, will represent the majority of
patients receiving chemotherapy.

Clinical Results

Approval of Neulasta was supported by two phase III clinical
trials involving subjects with breast cancer, who were undergoing
up to four cycles of chemotherapy. In six randomized clinical
studies, 465 subjects received one injection of Neulasta per
chemotherapy cycle, while 331 subjects received multiple Neupogen
injections per cycle. Neulasta provided protection from neutropenic
infection comparable to an average of 11 daily injections of
Neupogen.

Side Effects

Adverse events associated with the use of Neulasta may include
(but are not limited to) the following:

Bone pain

Muscle ache

Injection site reaction

Mechanism of Action

Neulasta (pegfilgrastim) is a protein that stimulates the
production of neutrophils, a type of white blood cell that is
depleted during cytotoxic chemotherapy. The stimulating factor acts
on hematopoietic cells by binding to specific cell surface
receptors to stimulate proliferation, differentiation, commitment
and end cell functional activation.